This invention relates to a method of treating gynecomastia in patients being treated with an antiandrogen who are in need of such treatment. This invention more particularly relates to a method of treating gynecomastia in benign prostatic hypertrophy patients being treated with an antiandrogen who are in need of such treating comprising administering to such patients in assocation with therapeutically effective amounts of an antiandrogen, an antiestrogen or an aromatase inhibitor or pharmaceutical compositions thereof.
U.S. Pat. No. 4,472,382, (Labrie et al.) discloses that prostate adenocarcinoma, benign prostate hypertrophy and hormone-dependent mammary tumors may be treated with various LH-RH agonists and that prostate adenocarcinoma and benign hypertrophy may be treated by use of various LH-RH agonists and an antiandrogen. However, there is no suggestion or disclosure of the present invention.
U.S. Pat. No. 4,659,695 (Labrie) discloses a method of treatment of prostate cancer in susceptible male animals including humans whose testicular hormonal secretions are blocked by surgical or chemical means, e.g., by use of an LH-RH agonist, e.g., [D-Trp.sup.6, des-Gly-NH.sub.2.sup.10 ]LH-RH ethylamide which comprises administering an antiandrogen, e.g., flutamide in association at least one antiandrogen, e.g., flutamide in association at least one inhibitor of sex steroid biosynthesis, e.g., aminoglutethimide and/or ketoconazole. However, there is no suggestion or disclosure of the present invention.
U.S. Pat. 3,995,060 (Neri et al.) discloses methods of preparing certain antiandrogens including 4'-substituted and 3',4'-disubstituted anilides, e.g. flutamide, and their use in treating androgen-dependent or androgen-caused disease states, such as prostatic adenocarcinoma benign prostate hypertrophy, hirsutism, and acne, in mammals, including man. However, there is no suggestion or disclosure of this invention.
Benign prostatic hypertrophy, a particularly common problem in older men, has been treated with antiandrogens and by use of estrogenic substances. The use of estrogenic substances has undesirable, life-threatening side effects due to the inherent properties of the estrogenic substances.
The use of antiandrogens while devoid of life-threatening side effects associated with treatment with estrogenic substances produces gynecomastia in 50 to 60% of non-castrated males studied, including normal subjects and advanced prostate cancer patients. Gynecomastia interferes with continued patient compliance with the antiandrogen therapy.
There is a need for a method of treating gynecomastia in patients being treated with an antiandrogen who are in need of such treatment.